ST AIA-PACK Intact PTH Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063605 FDA 510(k)
- FDA Product Code
- CEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1545 FDA 510(k)
- Regulation Number
- 862.1545 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ST AIA-PACK Intact PTH Assay is a radioimmunoassay for quantifying intact parathyroid hormone (PTH) in serum or plasma. It is classified as a Clinical Chemistry device and designed to measure whole PTH levels, distinguishing it from assays that detect only fragments. The assay employs a chemiluminescent detection method to provide precise and sensitive results, supporting diagnostic evaluation of parathyroid function and conditions such as hyperparathyroidism or hypoparathyroidism.
This assay is supplied as a single-use diagnostic kit and requires no special handling beyond standard laboratory procedures. It is intended for use in regulated clinical chemistry laboratories and complies with FDA 510(k) clearance (K063605) and In Vitro Diagnostic Device Directive (IVDD) requirements. The kit includes all necessary reagents and components for performing the assay, with no additional sterilisation or preparation beyond manufacturer instructions. Storage conditions are specified in the accompanying documentation, and the device is classified under EUDAMED regulation number 862.1545.
Frequently asked questions
What clinical conditions is the ST AIA-PACK Intact PTH Assay designed to help diagnose or monitor?
The ST AIA-PACK Intact PTH Assay is specifically designed to measure whole intact parathyroid hormone (PTH) levels in serum or plasma, distinguishing it from assays that detect only PTH fragments. This makes it useful for diagnosing and monitoring conditions like hyperparathyroidism or hypoparathyroidism, where accurate measurement of intact PTH is critical for assessing parathyroid function.
How is the ST AIA-PACK Intact PTH Assay supplied, and is it intended for single-use?
The ST AIA-PACK Intact PTH Assay is supplied as a single-use diagnostic kit, containing all necessary reagents and components for performing the assay. It requires no additional sterilization or special handling beyond following the manufacturer’s instructions, making it convenient for regulated clinical chemistry laboratories.
What type of detection method does this assay use, and why is it significant?
This assay employs a chemiluminescent detection method, which provides precise and sensitive results for quantifying intact PTH. This method enhances accuracy in diagnosing parathyroid-related conditions by improving the detection threshold and reducing potential interference compared to other assay techniques.
What regulatory approvals does the ST AIA-PACK Intact PTH Assay hold, and where is it authorized for use?
The ST AIA-PACK Intact PTH Assay holds FDA 510(k) clearance (K063605) and complies with the In Vitro Diagnostic Device Directive (IVDD). It is authorized for use in regulated clinical chemistry laboratories, adhering to both U.S. and EU regulatory standards, including EUDAMED regulation number 862.1545.
Does the assay require any special storage conditions beyond standard laboratory practices?
The ST AIA-PACK Intact PTH Assay does not specify unusual storage requirements beyond standard laboratory conditions. However, the exact storage instructions are detailed in the accompanying documentation provided by Tosoh Bioscience, ensuring proper handling and shelf-life compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K063605 | Class II | Active |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (2)
- FDA 510(k) K063605 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026